Custom Healthcare Systems Inc.

GUDID 20811870034583

CUSTOM HEALTHCARE SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 20811870034583
• NIH Device Record Key: 7d1e65cd-f2eb-41b6-82bf-ce3a0856da05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Healthcare Systems Inc.
• Version Model Number: KM34052226
• Company DUNS: 175254820
• Company Name: CUSTOM HEALTHCARE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811870034589 [Primary]
GS1	20811870034583 [Package]; Contains: 00811870034589; Package: NA [10 Units]; In Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

[20811870034583]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-17
• Device Publish Date: 2020-03-09

On-Brand Devices [Custom Healthcare Systems Inc.]

• 20811870035849: D36-15961
• 20811870035726: B9-17799D
• 20811870035719: B9-18944
• 20811870035610: UVA-17915
• 20811870035603: R1542
• 20811870035597: B9-16938
• 20811870035511: YM-18918
• 20811870035504: UNC-18917
• 20811870035481: B9-18914
• 20811870035283: D6-11243
• 20811870035245: UNC-18963
• 20811870035238: A3-7954
• 20811870035221: B9-18339
• 20811870035207: A3-7696
• 20811870035191: 6873011
• 20811870035177: D10-10698
• 20811870035146: D8-9560B
• 20811870035115: D36-18880
• 20811870035016: D8-9425B
• 20811870034965: B9-18863
• 20811870034958: D6-15955
• 20811870034934: BGI-18792
• 20811870034859: B9-18847
• 20811870034835: B9-18826
• 20811870034828: B9-18825
• 20811870034804: CDWS-18821
• 20811870034712: B9-18815
• 20811870034705: B9-18814
• 20811870034699: POK-18818
• 20811870034637: D36-18794
• 20811870034620: D20-15443LF
• 20811870034613: D20-11278LF
• 20811870034606: 3404253A
• 20811870034538: R1667
• 20811870034514: 5026CL-13
• 20811870034477: R1112B
• 20811870034446: S1528H
• 20811870034415: VBS-18520B
• 20811870034217: D363025A
• 20811870034132: MWM-18364C
• 20811870034125: CDWS-18374B
• 20811870034033: ZZ-0956
• 20811870034026: ZZ-0958
• 20811870033951: B9-16999B
• 20811870033920: CJD-16914
• 20811870033838: MANN-18617
• 20811870033807: ZZ-0960
• 20811870033739: B9-11260
• 20811870033654: D14-32C
• 20811870033616: D36-16229